Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer

NCT ID: NCT01937533

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-02

Study Completion Date

2019-05-31

Brief Summary

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This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value.

The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervical Cancer

Patients with presumed early cervical cancer being considered for curative surgery

Magnetic Resonance Imaging using an endovaginal receiver coil

Intervention Type PROCEDURE

Interventions

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Magnetic Resonance Imaging using an endovaginal receiver coil

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with presumed early stage cervical cancer being considered for curative surgery

Exclusion Criteria

* Ferromagnetic metal implants
* claustrophobia (MRI incompatibility)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Nandita deSouza

Professor of Translational Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nandita deSouza, Professor

Role: PRINCIPAL_INVESTIGATOR

ICR

Locations

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The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13/EE/0198 CCR3938

Identifier Type: -

Identifier Source: org_study_id

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